Neurofeedback basé sur l'IRMf pour soulager les hallucinations auditives résistantes aux médicaments (INTRUDE)
Traiter les hallucinations auditives réfractaires chez les patients schizophrènes avec le neurofeedback guidé par IRMf : un essai contrôlé randomisé
The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations. Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder. Based on this progress, we can track patients' hallucinatory status using real-time fMRI. We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. We will refer to a double-blind randomized placebo-controlled design. A total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 12 runs of either active or sham neurofeedback. The primary outcome measure will be the mean decrease of AHRS scores relative to baseline, and at 1 month post-treatment and re-evaluated at 2 months post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Renaud JARDRI, MD,PhD
- Numéro de téléphone: +33 0320445962
- E-mail: renaud.jardri@chru-lille.fr
Lieux d'étude
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Lille, France
- Recrutement
- Hop Fontan Chu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Right-handed female/male between 18 to 60 y.o.
- Schizophrenia (according to the DSM-5 classification)
- Frequent auditory hallucinations (SAPS item #1 ≥ 4)
- Stable medication for at least 30 days
- Absence of chronic neurological disorder (including seizure)
- Able to provide free written consent to participate in the research
Exclusion Criteria:
- Refusal to participate after clear and honest information about the study has been provided
- Clinical condition incompatible with the study protocol (e.g. agitation, severe disorganization, catatonia)
- Pregnancy
- Contraindication to MRI scan: pacemaker, ferromagnetic vascular clip, ferromagnetic foreign body
- Morphological criteria: weight >130kg, abdominal cirumference exceeding magnet aperture, shoulder width
- Claustrophobia
- Refusal to be informed of any incidental findings observed during the MRNI
- No social insurance
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Active
The visual feedback will correspond to instructions, adapted to the current hallucinatory state and decoded online from the fMRI signal. |
Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will continuously receive visual feedback (12 runs in total) computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. Two post-treatment visits are scheduled at 1 and 2 months to assess hallucinations severity. |
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Comparateur factice: Sham
The visual feedback will correspond to random instructions independently of the fMRI signal. |
Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will receive a random feedback (12 runs in total). Two post-treatment visits are scheduled at 1 and 2 months with the same clinical assessment than the active group. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
Délai: 1 month after treatment
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AHRS will be measured at t0 (randomization) and at 1 month after treatment Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms. |
1 month after treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in Auditory Hallucinations Rating Scale (AHRS) measure
Délai: 1 month and 2 months after treatment
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AHRS will be measured at t0 (randomization) and at 1 month after treatment The PANSS contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. rate from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210 |
1 month and 2 months after treatment
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Changes in global functioning relative to baseline
Délai: 1 month and 2 months after treatment
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Global Assessment of Functioning (GAF) is a numeric scale be measured at t0 (randomization) and at 1 month after treatment Scores range from 100 (extremely high functioning) to 1 (severely impaired). |
1 month and 2 months after treatment
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Changes in quality of life relative to baseline
Délai: 1 month and 2 months after treatment
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SQLS score will be measured at t0 (randomization) and at 1 month after treatment |
1 month and 2 months after treatment
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Changes in structural MRI markers relative to baseline
Délai: 1 month and 2 months after treatment
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Cortical thickness will be measured at t0 (randomization) and at 1 month after treatment |
1 month and 2 months after treatment
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Changes in structural MRI markers relative to baseline
Délai: 1 month and 2 months after treatment
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Gyrification Index will be measured at t0 (randomization) and at 1 month after treatment |
1 month and 2 months after treatment
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Changes in functional MRI markers relative to baseline
Délai: 1 month after treatment
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Brain activity at rest and connectivity metrics will be measured at t0 (randomization) and at 1 month after treatment |
1 month after treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Renaud JARDRI, MD,PhD, University Hospital, Lille
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020_08
- 2020-A00631-38 (Autre identifiant: ID-RCB number,ANSM)
- WP3 UNREHAL (Autre identifiant: PEPR PROPSY)
Informations sur les médicaments et les dispositifs, documents d'étude
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